Medical and Dental Device Patenting Blog : Medical and Dental Patent Lawyer & Attorrney : John Rizvi : Gold & Rizvi Law Firm : Florida, Serving Miami, Ft. Lauderdale, Orlando, Tampa, Florida

Osmolarity  vs. Osmolality - What a difference a single letter makes! 

Can getting a single letter of the alphabet wrong in an issued patent spell disaster when it comes to litigating against infringers?  Unless the mistake is seen as being a minor typographical error that can be corrected by filing a certificate of correction, the answer is a resounding yes.

 

Hats off to Peter Zura of The 271 Patent Blog for his post on Central Admixure Pharmacy Services v. Advanced Cardiac Solutions (06-13-07).

 In this case, Central Admixture Pharmacy Services sued Advanced Cardiac Solutions for patent infringment relating to a chemical solution used duriing heart surgery. 

A certificate of correction was sought on the patent and was issued by the patent office to replace all instances of the word "osmolarity" with the word "osmolality".

You might be thinking that all the certificate does is change the "R" in osmolaRity with a "L" so that it reads osmolaLity.  Well, yes, BUT.... 

Whether or not the certificate of correction is proper depends upon whether the change is a clerical or typographical nature or if it constitutes new matter or would require re-examination.  Although the district court found the certificate of correction proper, the CAFC disagreed and found that the result of the correction was to broaden the claims since the corrected claims using the term osmolaLity cover less concentrated solutions than the original osmolaRity.

Yikes!  Needless to say, non-technical proofreaders or computerized spell-check and grammar checking programs (gasp!) are not adequate alternatives to a careful final review of a patent application by someone familiar with the technical vocabulary of the invention.

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       As a Florida Patent Attorney, I track the news relevant to innovators in the medical field and post them here in my blog. Rather than straight reporting, one of the things I do is to give you insights you can use in your own innovations. For instance, today I read that the U.S. Patent Office has issued a patent for Hythiam Inc.'s PROMETA® alcohol and chemical dependence treatment program. I'll give you the scoop on what their patent covers, but I'll also point out the larger health trends the patent links to with the aim of spurring on your own ideation development.

       First, the scoop.

       According to an article at PharmaLive.com (Business Wire, LA, January 10, 2008) PROMETA® is a patented treatment program designed for healthcare providers with patients dependent on alcohol, cocaine, and methamphetamine independently or in combination. It's a holistic treatment program that incorporates nutritional supplements, psychosocial/other therapies chosen by the patient and her treatment provider, and FDA-approved medication given orally and intravenously, which are "separately administered in a unique dosing algorithm."

        As with any treatment program, PROMETA® was developed with the goal of "sustained recovery," What makes it patentable is partly the specifics of the integrated approach and partly the integration itself, which comes at alcohol and chemical addiction from disparate perspectives: the psychology of the individual on his own and in regard to his social environment, his physical health and potentially associated nutritional deficiencies, and a medical/pharmacological perspective.

       And, herein lies the insight.

       This treatment program fuses three macro cultural trends: 1.) An increasing emphasis on the mind-body connection; 2.) an underlying belief that no one perspective is universally "right;" and 3.) a belief that success with patients is borne partly in their own sense of responsibility and involvement.

         Interest in the mind-body connection in particular is a trend that has continued to grow over the last several years, and you can see this in patented products in virtually every category, including fitness, publishing, alternative health practices, the expansion of nutraceuticals into even our soda, etc.

        So, looking at the innovation you're currently or considering working on: Do any of these trends factor in? Could/should they? Or, is there another macro trend evident in your design? Honing in on a trend at play in the larger culture is a way of sharpening your idea and its development. I'm always looking for ways larger cultural trends impact and push forward innovation and would love to help keep the good ideas going with patents and trademarks that protect original, ingenious thinking.

        Contact me if you have an idea you'd like to protect - (866) 433-2288.

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The WIPO Patent Report, 2007 Edition, mentions that,

Increasing demand has led to increases in workload in some patent offices, although the number of patent applications pending examination differs significantly from one office to another. The United States of America had more than 900,000 pending applications in 2005, with Japan having the next largest number of pending applications (according to available data).

The following data will give you a better picture about this trend –

·        In 2005, about 1,660,000 patent applications were filed worldwide, which is an increase of 7% over 2004.

·        The average annual rate of increase in total patent filings since 1995 is 4.7%.

A bulk of this activity is concentrated in the US and medical technology patents lead the pack. I have already mentioned before how this surge is being accompanied by patent invalidation due to improper patenting methods being followed. With such heightened level of activity, it is becoming more and more important to get professional help while drafting patents, as every error is going to multiply the delays in the process, given the overburdened nature of the patent office at the present juncture.

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The Wall Street Journal sure thinks so. Here is an excerpt from a WSJ article titled ‘How a Patent Ruling Is Changing Court Cases’ that drives the point home –

Last week, a federal judge in San Francisco who previously had allowed a patent-infringement lawsuit [by Friskit] to proceed against RealNetworks Inc. changed course and dismissed the case, citing the Supreme Court's April ruling in KSR v. Teleflex. The case is believed to be the first in which a trial-court judge has reversed his position and dismissed a case in the defendant's favor, citing the KSR decision.

"The Supreme Court has made it clear what it thinks," the judge said at a hearing in the case. "Patents are being issued on obvious inventions, and it tightened the reins."

The Supreme Court laid out the obviousness doctrine in 1851, saying that a patent requires more "skill and ingenuity" than that of "an ordinary mechanic acquainted with the business." Since virtually every litigated patent case includes an assertion of obviousness, and since the U.S. patent office examines patent applications for obviousness, many legal commentators have called KSR the most important patent case in decades.

"Patentees have long had the upper hand in patent litigation but the KSR case has shifted that balance of power back to defendants," said Dennis Crouch, a law professor at the University of Missouri.

This means that applicants need to be much more careful while putting in their applications if they want the proceedings to progress without any hitches. The best, and ultimately cheapest, option would be to let experienced professionals handle the application procedure from the beginning, so that none of the problems arise later on to delay or derail the process.

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The Board of Patent Appeals and Interferences (BPAI) is presently experiencing a large increase in the number of ex parte appeals. In 2006 (Financial Year), the Board received 3,349 ex parte appeals. In 2007, the Board expects to receive more than 4,000 ex parte appeals; and in 2008, it expects to receive over 5,000 such appeals.

In order to keep the process functioning smoothly in the face of this increasing pressure, the patent office has proposed a new set of rules which have been designed to help the Board avoid new bottlenecks.

According to the patent office,

 

These rules are proposed to change procedures in such a way as to allow the Board to continue to resolve ex parte appeals in a timely manner.

The proposed rules do not propose to change any of the rules relating to inter partes reexamination appeals. Nor do the proposed rules propose to change any of the rules relating to contested cases.

These new rules might make life easier for the Board, but they also demand more precision and clarity from applicants who are submitting fresh appeals, thereby putting an extra burden on them.

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The importance of following proper rules and procedures in the filing of patents cannot be overemphasized. Even tiny mistakes can lead to patent invalidation. The Patent Prospector highlights a particular case where ‘double patenting’ finally led to invalidation of both patents.

An excerpt from the post:

Toprol-XL® is a drug used to treat heart-related malfunctions. Astra owns two patents for its active ingredient, metoprolol succinate; patents which Astra asserted against generic drug makers seeking FDA approval; patents with a peculiar pedigree. The district court found Astra's metoprolol patents invalid owing to double patenting, and inequitable conduct, owing to the peculiar pedigree.

The company has now appealed the invalidity finding of one asserted patent, not pursuing any further action on the other. Proper knowledge and/ or guidance about rules and regulations concerning patents would have saved Astra quite a bit of trouble in this regard.

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Can getting a single letter of the alphabet wrong in an issued patent spell disaster when it comes to litigating against infringers?  Unless the mistake is seen as being a minor typographical error that can be corrected by filing a certificate of correction, the answer is a resounding yes.

Hats off to Peter Zura of The 271 Patent Blog for his post on Central Admixure Pharmacy Services v. Advanced Cardiac Solutions (06-13-07).

 In this case, Central Admixture Pharmacy Services sued Advanced Cardiac Solutions for patent infringment relating to a chemical solution used duriing heart surgery. 

A certificate of correction was sought on the patent and was issued by the patent office to replace all instances of the word "osmolarity" with the word "osmolality".

You might be thinking that all the certificate does is change the "R" in osmolaRity with a "L" so that it reads osmolaLity.  Well, yes, BUT.... 

Whether or not the certificate of correction is proper depends upon whether the change is a clerical or typographical nature or if it constitutes new matter or would require re-examination.  Although the district court found the certificate of correction proper, the CAFC disagreed and found that the result of the correction was to broaden the claims since the corrected claims using the term osmolaLity cover less concentrated solutions than the original osmolaRity.

Yikes!  Needless to say, non-technical proofreaders or computerized spell-check and grammar checking programs (gasp!) are not adequate alternatives to a careful final review of a patent application by someone familiar with the technical vocabulary of the invention.

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